The following data is part of a premarket notification filed by Trophy with the FDA for Cs 8100sc, Cs8100sc Access.
| Device ID | K151087 |
| 510k Number | K151087 |
| Device Name: | CS 8100SC, CS8100SC Access |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | TROPHY 4 RUE F. PELLOUTIER Croissy-beaubourg, FR 77435 |
| Contact | Marie-pierre Labat-camy |
| Correspondent | Marie-pierre Labat-camy TROPHY 4 RUE F. PELLOUTIER Croissy-beaubourg, FR 77435 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-23 |
| Decision Date | 2015-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155319426 | K151087 | 000 |
| 60192155314568 | K151087 | 000 |
| 60192155314346 | K151087 | 000 |